Geriatric Distal Femur

NCT07237191 | Recruiting

• 1 other identifier: IRB00139405
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare two types of surgical fixation in patients with specific kinds of distal femur fractures. The main questions it aims to answer is which operation for distal femur fractures is better for efficient return to work and everyday activities.

Conditions

Articular Fractures

Keywords

distal femur fractures; single implant fixation; dual implant fixation

Outcome Measures

Primary Outcomes (3)

• Number of Unions

  Union, as determined by the treating surgeon, will be assessed via radiographs and documented as a dichotomous outcome (yes/no), and time to union will also be captured. Nonunion will be captured via surgeon diagnosis or return to the operating room for nonunion treatment.

  6-week, 3, 6, 12 months

• Total Surgical Time - Reoperations

  The total surgical time during any reoperations will be collected from the medical record.

  6-week, 3, 6, 12 months

• Number of Reoperations

  Details regarding reoperations will also be collected, whether or not the operation results in an inpatient admission.

  6-week, 3, 6, 12 months

Secondary Outcomes (20)

• Number of Resource Utilizations

  6-week, 3, 6, 12 month

• Return to Work - International Physical Activity Questionnaire (IPAQ) Scores

  Week 6

• Return to Work - International Physical Activity Questionnaire (IPAQ) Scores

  Month 3

• Return to Work - International Physical Activity Questionnaire (IPAQ) Scores

  Month 6

• Return to Work - International Physical Activity Questionnaire (IPAQ) Scores

  Month 12

Study Arms (2)

Single Implant Fixation

OTHER

Single implant fixation with either a precontoured lateral locking plate or an intramedullary nail which is the current standard of care.

Procedure: Single Implant Fixation

Dual Implant Fixation

OTHER

Dual implant fixation with either a lateral locking plate plus an intramedullary nail or a lateral locking plate plus a supplemental medial plate which is the current standard of care.

Procedure: Dual Implant Fixation

Interventions

Dual Implant Fixation PROCEDURE

Lateral precontoured distal femur plate and either (1) an intramedullary nail or (2) a medial plate. The medial plate must span the extra-articular portion of the fracture and must have stiffness of a 3.5 mm reconstruction plate, 3.5 mm limited contact dynamic compression plate, or greater.

Dual Implant Fixation

Single Implant Fixation PROCEDURE

Lateral precontoured 4.5 mm distal femur plate or an intramedullary nail at the surgeon's discretion. Standard-of-care techniques will be used by the surgeon for fracture reduction and implant placement.

Single Implant Fixation

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 55 years
• Surgically treated displaced distal femur extra articular or complete articular fractures

You may not qualify if:

• Patients with injury features that preclude treatment with 2 implants
• Patients unlikely to follow-up due to homelessness, or planning follow up at another institution
• Body Mass Index (BMI) \> 40
• Injury due to ground level fall
• Patient that speaks neither English or Spanish
• Patients with multisystem injuries that could preclude return to work
• \< 55 years of age
• Prisoner

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health

Charlotte, North Carolina, 28204, United States

RECRUITING

MeSH Terms

Conditions

Femoral Fractures, Distal

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Laurence Kempton, M.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurence Kempton, M.D.

CONTACT

7042553035; laurence.kempton@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Adult patients with extra-articular or complete articular distal femur fractures that will be operatively treated recruited from one of the participating sites during the index hospitalization

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: August 23, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)